European Drug Assessment Policy for Biological Medicine: Do You Know the Latest Developments—and Is Your Focus on CMC?

Biologics and chemical-based medicines are fundamentally different, nowhere so much as under CMC policy changes set forth recently by the EU. But savvy biologics makers are already seeing a double-barreled opportunity in the EU’s action — avoiding costly compliance errors while boosting sales in the bargain.

Keith Chidwick Ph.D. MBA untangles the complexities of the new European Drug Assessment Policy for Biological Medicines ... and points out the profit opportunities implicit in its provisions.

The impact of the new CMC policy is enormous, affecting drug and biologics makers in dozens of drug development and assessment areas. Dr. Chidwick guides you through the fine print, including key issues such as:

Eligibility and requirements to enter the centralized procedure

Game-changing issues including comparability, the main CMC reason for refusal

QbD as applied to biologics (this one could be your strike-it-rich bonanza!)

Strategic validation — understanding the big decisions that begin in early product development

Best practices for biosimilars in the EU, given that the CHMP (Committee for Medicinal Products for Human Use) is now experienced in biosimilars and certain common themes have been identified

And much more!

This new EU policy is a game-changer for drug and biologics makers. You fail to comply at your peril ... but proper compliance and understanding can fatten the bottom line. Who wouldn’t want that?

Auditors

Compliance officers

Consultants/service providers

Executive management

General/corporate counsel

Investigators

Managers

Manufacturing directors and supervisors

Personnel new to the industry

Pharmaceutical and cGMP auditors

Regulatory/legislative affairs professionals

Risk management specialists

Strategic planning and business development staff

Keith Chidwick Ph.D. MBA, Technical VP-PAREXEL Consulting, has built a reputation in international regulation of biotech medicines and as a venture capitalist. Both a biochemistry researcher and business developer, Dr. Chidwick developed large-scale bio-manufacturing processes; was responsible for the technology transfer; and became closely involved in the funding of small biotech companies. Public service roles include that of UK expert at EDQM P4 BIO and participating in other EMA Guideline Drafting groups; and serving on the control board of the National Institute of Biological Standards and Control (NIBSC).